Quality of life and patient satisfaction after implant-based breast reconstruction with or without acellular dermal matrix: randomized clinical trial.

backgroundAcellular dermal matrix (ADM) in implant-based breast reconstructions (IBBRs) aims to improve cosmetic outcomes. Six-month data are presented from a randomized trial evaluating whether IBBR with ADM provides higher health-related quality of life (HRQoL) and patient-reported cosmetic outcomes compared with conventional IBBR without ADM.

methodsIn this multicentre open-label RCT, women with breast cancer planned for mastectomy with immediate IBBR in four centres in Sweden and one in the UK were allocated randomly (1 : 1) to IBBR with or without ADM. HRQoL, a secondary endpoint, was measured as patient-reported outcome measures (PROMs) using three validated instruments (EORTC-QLQC30, QLQ-BR23, QLQ-BRR26) at baseline and 6 months.

resultsBetween 24 April 2014 and 10 May 2017, 135 women were enrolled, of whom 64 with and 65 without ADM were included in the final analysis. At 6 months after surgery, patient-reported HRQoL, measured with generic QLQ-C30 or breast cancer-specific QLQ-BR23, was similar between the groups. For patient-reported cosmetic outcomes, two subscale items, cosmetic outcome (8·66, 95 per cent c.i. 0·46 to 16·86; P = 0·041) and problems finding a well-fitting bra (-13·21, -25·54 to -0·89; P = 0·038), yielded higher scores in favour of ADM, corresponding to a small to moderate clinical difference. None of the other 27 domains measured showed any significant differences between the groups.

conclusionIBBR with ADM was not superior in terms of higher levels of HRQoL compared with IBBR without ADM. Although two subscale items of patient-reported cosmetic outcomes favoured ADM, the majority of cosmetic items showed no significant difference between treatments at 6 months. Registration number: NCT02061527 ( www.clinicaltrials.gov).